Bioequivalence: equivalent rate and extent of absorption
Bioequivalence means two products with the same active substance deliver it at the same rate and to the same extent, within accepted statistical limits.
It is the core evidence in a generic application under Article 10 of Directive 2001/83/EC. EMA's guideline on the investigation of bioequivalence requires the 90% confidence interval of the test-to-reference ratio for AUC and Cmax to fall within 80.00 to 125.00%, with tighter limits for narrow therapeutic index drugs. BCS-based biowaivers follow ICH M9.
Studies fail through poor comparator sourcing (it must be the EU reference product), high variability without a replicate design, and biowaivers for additional strengths that do not meet the proportionality and dissolution conditions.
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Before designing a study, check bioequivalence and biowaiver requirements against EMA guidance in Workbench, with every answer cited.
Related terms
- Reference product: reference medicinal productThe reference medicinal product is the product, authorised in the EU on a full dossier, whose data a generic or hybrid application relies on.
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- Generic application: abridged application under Article 10(1)A generic application under Article 10(1) of Directive 2001/83/EC authorises a copy of a reference product by relying on that product's data.
- Hybrid application: abridged application under Article 10(3)A hybrid application under Article 10(3) of Directive 2001/83/EC relies partly on a reference product's data and partly on new bridging studies.
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